All assays can be validated based on the relevant guidelines and white papers. Statistical evaluation and data transfer agreements can be discussed with the sponsor.
VelaLabs has currently 3 Analytical Project Manager (APMs) for the analytical coordination of your clinical study available. Cooperation with local companies expand our services for further support on clinical kits or study protocols.
1. Pharmacokinetic studies (PK)
- ECL (Electrochemiluminescence; MSD-MesoScaleDiscovery)
- Other methods upon request
2. Pharmacodynamic studies (PD)
- Dependent on request
- e.g. (q)PCR, Bioassays, cytokine multiplexing…
3. Immunogenicity profiling / Anti drug antibodies (ADA)
- Screening assay
- Confirmation assay
- Titer assay
- Neutralization assays
For the evaluation of the ADA various technologies (e.g. MSD or SPR/Biacore) as well our highly experienced cellbased assay group are available for discussion.